MoCRA — what to check before selling cosmetics in the U.S.

This article is general information, not legal or tax advice. It requires review by U.S. accounting and legal professionals before publication.

MoCRA (the Modernization of Cosmetics Regulation Act of 2022) is the largest change to U.S. cosmetics regulation in decades. Any K-Beauty company planning to sell in the U.S. should check it before launch.

Key duties

• Facility registration: FDA registration of facilities that manufacture or process cosmetics sold in the U.S.
• Product listing: submitting the products you sell and their ingredients
• Responsible person: the party named on the label, with contact details
• Safety substantiation: keeping records that support product safety
• Adverse event reporting: reporting serious adverse events within the deadline

Some small businesses may qualify for exemptions. Confirm detailed requirements and timelines against FDA guidance.

Who handles what

MoCRA compliance is specialist regulatory work. Hubtax does not provide it directly; we work with a regulatory consulting partner. Hubtax coordinates the overall plan so the entity, the responsible-person structure on the label, and the import and distribution timeline line up with regulatory deadlines.

In short

The label and responsible person are tied to your entity structure. Checking regulatory requirements before forming the entity helps avoid reprinting labels.